Quality Director/Head, Europe

Quality Director/Head, Europe

Company: Biotechnology company

Job Title: Quality Director/Head, Europe

Location: Zug, Switzerland

Reports to: Managing Director

Role Overview

A leading global biotechnology company is searching for a new Quality Director/Head, Europe, to join their European Head-Quarters in Switzerland. Your responsibilities will include; managing the Quality Management of the company; act as the Responsible Person and the main point of contact to Swiss Health Authorities, as well as FDA/EMEA; coordinate the global Quality Management Systems for the supply chain; and ensure GxP compliances are upheld.

This role will also be responsible for formulation, coordinating, and implement global Quality Strategy and Agreements that are fundamental to the continued success of the business.

Key Responsibilities

• Manage and oversee suppliers, services, and Contract Manufacturing Organisations (CMOs)
• Oversee and conduct inspections/audits of suppliers and CMOs
• Determine Quality Agreements and Quality framework
• Preserve and improve the existing global Quality Management Systems
• Oversee all GMP requirements for Quality; deviations, CAPAs, changes
• Conduct internal/external audits
• Safeguard GxP certification and licenses and ensure all is up-to-date
• Be the Quality authority and point of contact for local and international health authorities

Essential Criteria

• Extensive strategic experience in Quality
• Extensive leadership experience
• Recruitment/Hiring strategy experience for Quality
• Extensive GMP/GDP experience
• Audit experience, experience with CMOs is ideal
• Fluent English (writing and speaking)

Compensation

• Full-time employment
• Basic salary: 150,000 - 200,000 CHF (depending on experience)
• Annual performance bonus
• Pension/additional benefits

If you this is a position of interest, and you would like to know more or have any additional questions, please submit a copy of your CV to the following email address;